Efficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate Hyperlipidemia

Olive Lifesciences

Status: Unknown

Conditions: Hyperlipidemia; Chronic Smokers

Treatments: Dietary Supplement: BioTurmin (Curcuma longa rhizomes extract); Dietary Supplement: MaQxan; Dietary Supplement: BioTurmin-WD (Water dispersible curcuminoids); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02203227

OLS-SH/06-14 VER 01

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in chronic smokers having mild to moderate hyperlipidemia after 30 and 60 days of intervention.

Full description

In a randomized, double-blind, placebo control trial, the efficacy and safety of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) will be investigated in chronic smokers having mild to moderate hyperlipidemia. Sixty subjects will be randomly assigned to receive the dietary supplements and placebo for 60 days. The efficacy of the supplements will be measured by estimating cotinine and malondialdehyde level.

Enrollment: 60 estimated patients

Sex: Male

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men > 20 years
• Chronic cigarette/ beedi smoker (2-3 packets/day since last 3 years or more) with mild to moderate hyperlipidemia (LDL ranging 160-189 mg/dL, TC >200 mg/dL and/or HDL-C <40 mg/dL)
• Being mentally competent and able to understand all study requirements and sign the informed consent form.

Exclusion criteria

• Patients with Chronic obstructive pulmonary disease (COPD)
• Women
• Patients with severe liver, renal, cardiac or brain diseases.
• Unable to complete follow up.
• Subjects on any medication like diuretics.
• Allergic to any medication.
• With a history of alcohol and/or drug abuse.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Capsule containing 250 mg of placebo, two times a day

Treatment:

Dietary Supplement: Placebo

BioTurmin

Experimental group

Description:

Capsule containing 250 mg of BioTurmin (Curcuma longa rhizomes extract), two times a day

Treatment:

Dietary Supplement: BioTurmin (Curcuma longa rhizomes extract)

BioTurmin-WD

Experimental group

Description:

Capsule containing 250 mg of BioTurmin-WD (water dispersible curcuminoids), two times a day

Treatment:

Dietary Supplement: BioTurmin-WD (Water dispersible curcuminoids)

MaQxan

Experimental group

Description:

Capsule containing 10 mg of MaQxan (Tagetes erecta flower extract), two times a day

Treatment:

Dietary Supplement: MaQxan